Spatial NeglectNCT07519317
Dosing and Deployment Trial: A Home-based Optokinetic Treatment
A study testing Optokinetic stimulation in people with Spatial Neglect, run by Duke University.
Trial summary
Several interventions exist for remediation of spatial neglect, but they have mixed evidence. Optokinetic stimulation is a bottom-up intervention; in other words, it is a stimulus-driven process, with Level A (strongest) evidence, and is recommended in clinical practice guidelines such as the American Heart… Read more about this study
- Who is it for?
- Ages 60 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Neglect
- What is being tested?
- Optokinetic stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 16 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first and unilateral right brain damage stroke, confirmed by medical records,
- time post stroke >6 months,
- moderate to severe SN, classified using the Catherine Bergego Scale (CBS) via the Kessler Foundation Neglect Assessment Process (KF-NAP),
- over age of 60 years, and
- IGD noted either on the KF-NAP or neuroimaging from medical records.
- a current care partner (defined as someone providing care and assistance) of a stroke survivor living with SN,
- English speaker,
- the stroke survivor they are caring for has been enrolled into the study.
Who cannot join
- history of multiple strokes or neurological incidents (e.g., traumatic brain injury, seizures, or brain tumor),
- unable to communicate through spoken English, screened using the Aphasia Rapid Test (ART), as instructions for treatment and assessment tasks will be provided verbally in English,
- cognitive impairment as defined by the Blind-MoCA,
- dependent in mobility- walking or wheelchair via medial chart,
- legally blind per medical chart,
- home located out of a 50-mile radius from Duke University, making it too costly for the frequent home visits, and
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- no IGD present.
- not a care partner currently,
- can't speak English,
- the stroke survivor didn't consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dosing and Deployment Trial: A Home-based Optokinetic Treatment for Ipsilesional Gaze Deviation
Several interventions exist for remediation of spatial neglect, but they have mixed evidence. Optokinetic stimulation is a bottom-up intervention; in other words, it is a stimulus-driven process, with Level A (strongest) evidence, and is recommended in clinical practice guidelines such as the American Heart Association's stroke guidelines. The studies currently published all use varing doses (number of sessions a week), did not assess the impact on mobility and risk of falls, and have not been implemented in the home setting. It is imperative to understand how to successfully implement this intervention at home, and learn how it will impact mobility in order to better support a large population of individuals living with chronic spatial neglect and who face barriers to accessing care because they require caregiver support to leave the home. This will be done using both qualitative and quantitative methods.
Read the detailed description
Stroke is a leading cause of disability among adults in the United States (US) and increases the risk of falls. One factor associated with excess fall risk after stroke is spatial neglect, which occurs in 54% of right brain damaged stroke survivors. Spatial neglect is caused by damaged neural networks critical for spatial attention. A hallmark symptom of spatial neglect is ipsilesional gaze deviation (IGD) , which is a sustained horizontal gaze preference toward the affected brain hemisphere. Since IGD is a major predictor of poor recovery-adversely affecting daily activities and functional mobility, and extending hospital stays because of falls-intervention is necessary. And because of the challenges of the traditional rehabilitation paradigm (short length of stay), there is a significant need for an intervention, accessible to individuals living at home with SN, that will improve mobility and risk of falls.
Optokinetic stimulation is a treatment shown to induce brain neural plasticity and improve spatial exploration, in turn reduce spatial neglect symptoms, including IGD, experienced in daily life. Optokinetic stimulation requires the participant to follow one step command: "follow the targets with your eyes". The target is a small dot that moves across the computer screen. The literature shows variation in implementation because users (mostly therapists) were required to create their own optokinetic stimulation, until just recently when Eyemove was developed. Eyemove is computer-based intervention developed to standardize the way optokinetic stimulation is administered, via an inexpensive, commercially available software program.
Via a randomized clinical trial, the researchers plan to focus on dose and feasibility in the home setting to answer the specific aims.
The study will randomize stroke participants who meet all inclusion and exclusion criteria into two intervention dose groups. Group 1 will complete 3-sessions of Eyemove, and Group 2 will complete 5-sessions of Eyemove, all within 7-9 days. Outcomes will be measured at baseline, before and after the treated period. Screening and pre-treatment assessments will take approximately 2 hours, and the post assessments will take approximately 1 hour. The post-treatment assessments will be conducted 14 days after the pre-treatment assessments.
In the interest of feasibility and limiting unnecessary burden on participants, the study team will then conduct semi-structured interviews pre-treatment with at least the first 8 stroke participants who are randomized into each group. The study team will interview them again post-treatment and will also interview care partners of stroke survivors at time of screening and pre-treatment assessment, to participate in semi-structured interviews and two assessments. The researchers will also plan to conduct these with the first 8 care partners from each group, which will be determined after the stroke survivor is randomized.
- Conditions
- Spatial Neglect
- Being tested
- Optokinetic stimulation
- Keywords
- spatial neglect; optokinetic stimulation; stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optokinetic stimulationBehavioural
Visual scanning (repeated eye movements) from one side of the computer to the neglected side of space. The target is 30 to 70 dots, randomly displayed (of all colors, size: 2- 4 cm) on a dark background on a computer screen.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Active comparator | 3 50-minute sessions of optokinetic stimulation over 7-9 days Receives: Behavioral: Optokinetic stimulation |
| Treatment Group 2 | Active comparator | 5 50-minute sessions of optokinetic stimulation over 7-9 days Receives: Behavioral: Optokinetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mobility Assessment Course
Evaluates a person's mobility, using visual search multitask, to assess neglect, and its relation with existing neglect tasks. The change in score from pre- to post-treatment is the primary outcome measure of the study. For this assessment, the focus on side-to side spatial imbalance (the total score is the difference between targets found on the right versus the left side). There are 40 targets (20 on each side). Lower total score indicates a poorer performance (0-40). The mean control asymmetry= 0.75 (SD=0.81), and if the asymmetry score is greater or equal to 2.78, neglect is present.
Measured: 20 minutes
Secondary outcomes (3)
Health-ITUES
A 20-item questionnaire that evaluates the impact, perceived usefulness, perceived ease of use about a specific technology. The change in score from pre- to post-treatment is a secondary outcome measure of the study. The score is calculated as the mean of all items with each item weighted equally. The higher the score, the more usable the person feels the technology is. Range of possible scores is 1 to 5.
Measured: 10 minutes
Stroke Assessment of Fall Risk
A tool which includes items related to stroke-specific neurologic deficits to determine the ability to predict falls. The change in score from pre- to post-treatment is a secondary outcome measure of the study. If the total score has 0 yes responses- there is low fall risk. If the total score = 1 yes response, then there is a level 1 fall risk. And if the total score =2 or more yes responses, or any yes response to item 3 (nursing judgment) then this is a Level 2 fall risk (highest amount).
Measured: 10 minutes
Caregiver Burden Scale
A 22-item scale to determine burden that is experienced by care partners. The change in score from pre- to post-treatment is a secondary outcome measure of the study. There are multiple categories in this scale. Items 1-8 gains insight into general strain, 9-11 captures information on isolation, and 12-16 captures information on disappointment, and 17-19 on emotional involvement, and 20-22 on environmental burden. The higher the score the more burden the caregiver has (range from 1 (not at all) to 88 (often)).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start4 Jan 2027 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion16 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial NeglectStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with both qualitative and quantitative methods.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Hreha, EdD, OTR/L, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519317
- Sponsor's protocol ID
- Pro00118913
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing and Deployment Trial: A Home-based Optokinetic Treatment for Ipsilesional Gaze Deviation
- ClinicalTrials.gov ID
- NCT07519317
- Acronym / sponsor ID
- Pro00118913
- Conditions
- Spatial Neglect
- Keywords
- spatial neglect; optokinetic stimulation; stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 16 Jun 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several interventions exist for remediation of spatial neglect, but they have mixed evidence. Optokinetic stimulation is a bottom-up intervention; in other words, it is a stimulus-driven process, with Level A (strongest) evidence, and is recommended in clinical practice guidelines such as the American Heart Association's stroke guidelines. The studies currently published all use varing doses (number of sessions a week), did not assess the impact on mobility and risk of falls, and have not been implemented in the home setting. It is imperative to understand how to successfully implement this intervention at home, and learn how it will impact mobility in order to better support a large population of individuals living with chronic spatial neglect and who face barriers to accessing care because they require caregiver support to leave the home. This will be done using both qualitative and quantitative methods.
Detailed description
Stroke is a leading cause of disability among adults in the United States (US) and increases the risk of falls. One factor associated with excess fall risk after stroke is spatial neglect, which occurs in 54% of right brain damaged stroke survivors. Spatial neglect is caused by damaged neural networks critical for spatial attention. A hallmark symptom of spatial neglect is ipsilesional gaze deviation (IGD) , which is a sustained horizontal gaze preference toward the affected brain hemisphere. Since IGD is a major predictor of poor recovery-adversely affecting daily activities and functional mobility, and extending hospital stays because of falls-intervention is necessary. And because of the challenges of the traditional rehabilitation paradigm (short length of stay), there is a significant need for an intervention, accessible to individuals living at home with SN, that will improve mobility and risk of falls.
Optokinetic stimulation is a treatment shown to induce brain neural plasticity and improve spatial exploration, in turn reduce spatial neglect symptoms, including IGD, experienced in daily life. Optokinetic stimulation requires the participant to follow one step command: "follow the targets with your eyes". The target is a small dot that moves across the computer screen. The literature shows variation in implementation because users (mostly therapists) were required to create their own optokinetic stimulation, until just recently when Eyemove was developed. Eyemove is computer-based intervention developed to standardize the way optokinetic stimulation is administered, via an inexpensive, commercially available software program.
Via a randomized clinical trial, the researchers plan to focus on dose and feasibility in the home setting to answer the specific aims.
The study will randomize stroke participants who meet all inclusion and exclusion criteria into two intervention dose groups. Group 1 will complete 3-sessions of Eyemove, and Group 2 will complete 5-sessions of Eyemove, all within 7-9 days. Outcomes will be measured at baseline, before and after the treated period. Screening and pre-treatment assessments will take approximately 2 hours, and the post assessments will take approximately 1 hour. The post-treatment assessments will be conducted 14 days after the pre-treatment assessments.
In the interest of feasibility and limiting unnecessary burden on participants, the study team will then conduct semi-structured interviews pre-treatment with at least the first 8 stroke participants who are randomized into each group. The study team will interview them again post-treatment and will also interview care partners of stroke survivors at time of screening and pre-treatment assessment, to participate in semi-structured interviews and two assessments. The researchers will also plan to conduct these with the first 8 care partners from each group, which will be determined after the stroke survivor is randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with both qualitative and quantitative methods.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Active comparator | Behavioral: Optokinetic stimulation3 50-minute sessions of optokinetic stimulation over 7-9 days |
| Treatment Group 2 | Active comparator | Behavioral: Optokinetic stimulation5 50-minute sessions of optokinetic stimulation over 7-9 days |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- first and unilateral right brain damage stroke, confirmed by medical records,
- time post stroke >6 months,
- moderate to severe SN, classified using the Catherine Bergego Scale (CBS) via the Kessler Foundation Neglect Assessment Process (KF-NAP),
- over age of 60 years, and
- IGD noted either on the KF-NAP or neuroimaging from medical records.
Key exclusion criteria (10 listed)
- history of multiple strokes or neurological incidents (e.g., traumatic brain injury, seizures, or brain tumor),
- unable to communicate through spoken English, screened using the Aphasia Rapid Test (ART), as instructions for treatment and assessment tasks will be provided verbally in English,
- cognitive impairment as defined by the Blind-MoCA,
- dependent in mobility- walking or wheelchair via medial chart,
- legally blind per medical chart,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optokinetic stimulationVisual scanning (repeated eye movements) from one side of the computer to the neglected side of space. The target is 30 to 70 dots, randomly displayed (of all colors, size: 2- 4 cm) on a dark background on a computer screen. | Behavioural | Treatment Group 1, Treatment Group 2 |
Primary outcome
The Mobility Assessment Course
Time frame: 20 minutes
Evaluates a person's mobility, using visual search multitask, to assess neglect, and its relation with existing neglect tasks. The change in score from pre- to post-treatment is the primary outcome measure of the study. For this assessment, the focus on side-to side spatial imbalance (the total score is the difference between targets found on the right versus the left side). There are 40 targets (20 on each side). Lower total score indicates a poorer performance (0-40). The mean control asymmetry= 0.75 (SD=0.81), and if the asymmetry score is greater or equal to 2.78, neglect is present.
3 secondary outcomes
Health-ITUES
Time frame: 10 minutes
Stroke Assessment of Fall Risk
Time frame: 10 minutes
Caregiver Burden Scale
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Spatial Neglect
Recruiting
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Stroke, Unilateral Spatial Neglect
Recruiting
Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Spatial Neglect After Right Brain Stroke
Not yet recruitingObservational study
Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
Stroke, Spatial Neglect
Recruiting
Comparing Prism Adaptation Training With and Without TENS to Minimize Unilateral Spatial Neglect
Unilateral Spatial Neglect, Stroke
Active, not recruitingObservational study
A Biomarker for Personalized Care in Post-Stroke Spatial Neglect
Spatial Neglect, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Hreha, EdD, OTR/L principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Optokinetic stimulation in people with Spatial Neglect, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Hreha, EdD, OTR/L (919-660-7596, kimberly.hreha@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mobility Assessment Course (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.